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In a widely anticipated decision, the Supreme Court reversed the
Federal Circuit's decision in Mayo v. Prometheus, which had
upheld the patentability of a medical diagnostic test that measured
metabolites in human blood. This decision has wide-ranging
implications for the medical diagnostic community, as it throws
into question the patentability of medical diagnostic tests and may
raise patentability issues for other industries as well.
Justice Breyer, writing on behalf of the unanimous Supreme
Court, reiterated that "laws of nature, natural phenomena and
abstract ideas are not patentable." Justice Breyer explained
that "Einstein could not patent his celebrated law that E=mc2;
nor could Newton have patented the laws of gravity." Justice
Breyer did note, however, that the Court has held that "a
process is not unpatentable simply because it contains a law of
nature or a mathematical algorithm...and added that 'an
application of a law of nature or mathematical formula to a known
structure or process may well be deserving of patent
protection.'"
Justice Breyer stated that this case "lies at the
intersection of these basic principles...The claims purport to
apply natural laws describing the relationships between the
concentration in the blood of certain thiopurine metabolites and
the likelihood that the drug dosage will be ineffective or induce
harmful side-effects. We must determine whether the claimed
processes have transformed these unpatentable natural laws into
patent eligible applications of those laws."
The Court held that the claims were unpatentable because they
essentially applied only a law of nature, "[n]amely,
relationships between concentrations of certain metabolites in the
blood and the likelihood that a dosage of a thiopurine drug will
prove ineffective or cause harm." The Court reached this
conclusion by categorizing the patents into three steps, consisting
of an administering step, a "wherein" clause and a third
determining step. With respect to the administering step, the Court
found that this merely refers to the relevant audience, i.e., the
doctors who treat patients. The "wherein" clause merely
described the natural law. The third step, the determining step
only tells the doctor to determine the level of the relevant
metabolites in the blood. The Court found that this step merely
told the doctors to engage in "well-understood, routine,
conventional activity previously engaged in by scientists who work
in the field." Finally, the Court found that "the three
steps as an ordered combination adds nothing to the laws of nature
that is not already present when the steps are considered
separately."
The Supreme Court's decision raises more questions than it
answers and it simultaneously calls into question the patentablity
of diagnostic methods that have wide ranging value. While not going
so far as to exclude the patentability of diagnostic methods per
se, the Supreme Court did not provide clear guidance on what types
of diagnostic tests may remain patentable. Given the lack of
guidance from the Supreme Court's decision, we can expect
further decisions from lower courts and the Federal Circuit testing
the patentability requirements of medical diagnostic methods.
Mayo Collaborative Services v. Prometheus Laboratories Inc.,
556 U.S. ____(2012).
This article originally appeared in the Orange County
Business Journal.
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